Webinars
GPEx® Lightning: Achieving Rapid, High-Titer Expression for Next-Generation Biologics
In this webinar learn how the GPEx® Lightning platform accelerates the high-titer production of next-generation multispecific antibodies and complex protein biologics
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White Papers
White Paper - Biocapacitance Measurement: A PAT Tool for Biomass Measurement in an Upstream Process
Biocapacitance technology is an online PAT tool for continuous monitoring of biomass in a mammalian or microbial bioprocess. In this paper, we show three applications of biocapacitance measurement technology.
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Article
GMP-Compliant iPS Cell Lines Show Widespread Plasticity in a New Set of Differentiation Workflows for Cell Replacement And Cancer Immunotherapy
This article discusses the development and establishment of Good Manufacturing Practice (GMP) compliant workflows for generating induced pluripotent stem cell (iPSC) lines and their differentiated progeny for cell therapeutic applications.
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Executive Summary
Webinar E-summary UpTempo℠ Antibody: A Streamlined Platform Process to Accelerate Biotherapeutics from Gene to Clinic
Catalent’s UpTempo℠ Antibody platform process combines the industry-leading GPEx® cell line development technology with streamlined, phase appropriate drug substance development to deliver products from early-stage development through CGMP manufacturing.
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Executive Summary
A Guide to Optimizing Analytical Strategies Throughout the Biologics Development Life Cycle
Cell-based assays play a critical role in assessing potency for traditional biologics and advanced therapeutics. For all analytical methods, increasing accuracy and precision while decreasing variability are critical to optimizing a method. For a cell-based assay, due to their biologic nature, the variable material inputs provide a challenge.
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Executive Summary
Quality by Design (QbD) for Biologics from a CDMO Perspective
Cell-based assays play a critical role in assessing potency for traditional biologics and advanced therapeutics. For all analytical methods, increasing accuracy and precision while decreasing variability are critical to optimizing a method. For a cell-based assay, due to their biologic nature, the variable material inputs provide a challenge.
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Executive Summary
Catalent’s Advanced Bioassay for Evaluating Cell Response
Cell-based assays play a critical role in assessing potency for traditional biologics and advanced therapeutics. For all analytical methods, increasing accuracy and precision while decreasing variability are critical to optimizing a method. For a cell-based assay, due to their biologic nature, the variable material inputs provide a challenge.
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Article
Article: Unveiling the Critical Pathways in AAV Potency Evaluation and Future Trends in Gene Therapy
In this expert roundtable, three experienced professionals from the rapidly evolving gene therapy field delve into the crucial assessment of AAV potency and its profound influence on the industry's progress.
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Video
Video: Unveiling the Critical Pathways in AAV Potency Evaluation and Future Trends in Gene Therapy
In this expert roundtable, three experienced professionals from the rapidly evolving gene therapy field delve into the crucial assessment of AAV potency and its profound influence on the industry's progress.
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Webinars
UpTempo Antibody: A Streamlined Platform Process to Accelerate Biotherapeutics from Gene to Clinic
Watch this webinar to find out how UpTempo Antibody addresses key challenges bringing antibody therapeutic programs to clinical trials.
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